FDA Approves a First-of-Its-Kind Pill to Cut Cholesterol in High-Risk Patients
The once-daily tablet lowered LDL cholesterol by up to 60% in trials and could widen access to a therapy long limited to injections.
- On Thursday, the Food and Drug Administration approved Merck's Lipfendra, the first oral PCSK9 inhibitor for treating high cholesterol, bolstering the company's efforts to diversify beyond its blockbuster cancer treatment Keytruda.
- The cholesterol market is currently dominated by expensive injectable PCSK9-inhibitor drugs like Amgen's Repatha and Sanofi's Praluent, yet only 1% of 6 million eligible patients use these injectables, which cost up to $600 monthly.
- With a list price of $315 for a 30-day supply, Lipfendra lowers LDL cholesterol levels by up to 60% by blocking the PCSK9 protein, offering a more convenient alternative to injections.
- Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston, said the approval is "thrilling," while Merck Research Laboratories president Dr. Dean Li noted the drug is easy for primary care doctors to prescribe.
- Scotiabank analyst Louise Chen projects "peak sales potential of tens of billions of dollars," as Merck studies if Lipfendra reduces heart attack risks while Keytruda patent protections expire in 2028.
130 Articles
130 Articles
Lipfendra works by blocking the PCSK9 protein, regulating cholesterol levels. It offers a viable alternative to injectable treatments
FDA approves cholesterol pill from Merck
US drug regulators signed off on a new pill designed to lower cholesterol levels far beyond what traditional statins can achieve. Merck’s Lipfendra achieved similar results to injectable treatments, potentially heralding a new era of easier prevention for people wanting to bring down artery-clogging cholesterol. “This is a game changer,” one cardiologist said, adding that many patients were hesitant to go on the injection treatment. Heart diseas…
The Food and Drug Administration (FDA) on Thursday approved a daily pill that can reduce cholesterol levels well below what can be achieved with statins, the affordable pills to reduce cholesterol. The medicine, the licitide, whose brand name is Lipfendra, is manufactured by the pharmaceutical company Merck. Clinical trials have shown that it can reduce LDL levels — the dangerous type of cholesterol — to 50 or 60 or even less. Adults who do not …
FDA nod to Merck's cholesterol pill opens a new frontier in cardiovascular care
The Food and Drug Administration has approved a first-of-its-kind pill that can drastically reduce cholesterol in a way that’s previously only been possible through expensive, injectable drugs. The drug from Merck was OK’d on Thursday for patients with artery-clogging cholesterol that persists even after taking statins, the standard medications for cutting heart attack risk. Merck will market its pill under the brand name Lipfendra. It’s the fir…
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